FDA accepts Nuvation Bio’s NDA for taletrectinib to treat ROS1+NSCLC

Nuvation Bio (NUVB) announced that the U.S. FDA has accepted the company’s NDA for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor TKI , for the treatment of advanced ROS1+ NSCLC . The U.S. FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act PDUFA goal date of June 23, 2025. Priority Review designation underscores the significant advancement taletrectinib may offer patients with ROS1+ NSCLC, for which there remains a high unmet need for new treatment options. Taletrectinib previously received Orphan Drug Designation and is the only ROS1 TKI currently in development that has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs. “We are thrilled to reach this important milestone for taletrectinib, a significant step forward for people living with ROS1-positive NSCLC who urgently need new treatment options,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “With data from over 300 patients-the largest ROS1-positive NSCLC dataset to date supporting an original NDA-taletrectinib has demonstrated the potential to deliver durable and meaningful benefits.”